Designing a Registration Stability Study from Scratch

Stability storage and testing

During this webinar, Dr. Mark Powell provides guidance on the design of long-term stability studies in support of a MAA or NDA. As well as describing the general requirements for different dosage forms, differences in expectations between EU and US regulators were highlighted. Depending on the dosage form and pack type, certain risks require mitigation prior to registration batch manufacture and stability set-down: these were also discussed. Confidence in test methods and a plan for low-level impurity data reporting are also important elements. Finally, study designs were discussed, including different product configurations and requirements for registration in Climatic Zones III and IV.

Topics covered included:

  • Regulatory expectations for different dosage forms
  • Product knowledge
  • Test method and data reporting considerations
  • Study design
  • Different strengths/primary pack configurations
  • Considerations for global registration